Core Points - The article emphasizes the importance of understanding FDA regulations for Chinese companies exporting food, drugs, medical devices, cosmetics, and health products to the U.S. [1] - It outlines the critical steps and requirements for successful FDA customs clearance, highlighting the necessity of prior preparation over post-remedy actions [2][3] Group 1: FDA Clearance Prerequisites - Not all goods require FDA clearance, but specific categories are heavily regulated, including food, drugs, medical devices, cosmetics, veterinary products, and radiation-emitting products [2] - The first step for clearance is having valid "company registration" and "product listing" with the FDA; without these, goods will be automatically detained upon arrival [2][3] Group 2: Key Conditions for FDA Clearance - All foreign companies exporting FDA-regulated products must register with the FDA and designate a U.S. agent for communication [3][4] - Products must be listed in the FDA database after company registration, which is essential for compliance [3][4] - The registration number and product listing number on customs declarations must match the FDA database exactly to avoid delays [4] Group 3: Compliance and Notification Requirements - Importers must have a legitimate U.S. company identity and are responsible for the safety and compliance of imported products [4] - Pre-notification to the FDA is required for certain products before arrival, with specific timeframes for submission [4] - Importers may need to provide technical documents and testing reports to prove compliance with U.S. standards [4] Group 4: Common Reasons for Detention and Solutions - Common reasons for detention include labeling issues, non-compliance with ingredient regulations, lack of necessary pre-approval, and hygiene problems [9] - If detained, importers can submit evidence for a hearing, conduct repairs or testing under FDA supervision, re-export the goods, or, as a last resort, destroy the goods [9]